A Woman's Path to Recovery (WPR) is an evidence-based gender-specific treatment model for women with substance use disorder. It is a 12-session model that is conducted once per week in individual modality, with eight core sessions and four session topics that participants can select from a larger menu.

Twelve-Step Facilitation (TSF) consists of a brief, structured, and manual-driven approach to facilitating early recovery from alcohol abuse/alcoholism and other drug abuse/addiction. It is intended to be implemented on an individual basis in 12 to 15 sessions and is based in behavioral, spiritual, and cognitive principles that form the core of 12-step fellowships such as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA).

Detailed Description:

Anticipated Impacts on Veterans' Healthcare: Our study will obtain important scientific and clinical knowledge about the efficacy of an evidence-based gender specific model of treatment (A Woman's Path to Recovery) for women veterans with substance use disorder (SUD), compared to an existing model that is not gender specific (12-Step Facilitation). 12-Step Facilitation focuses on encouraging attendance at 12-step groups such as Alcoholics Anonymous. If the gender-specific approach to treatment is more effective than 12-Step Facilitation for veterans with SUD in the VA, it may substantially improve the physical and mental health outcomes of women veterans, and decrease healthcare costs by providing a replicable method for delivering treatment.

Project Background: SUD is common among women veterans, and on the rise among younger women veterans. As more women veterans seek treatment at the VA, there is likely to be an increased need for evidence-based treatment of SUD. To our knowledge, the PI has developed the only gender-based treatment approach that has shown significant outcomes in a pilot trial, on multiple domains. This proposal represents an opportunity to evaluate its efficacy with women veterans, including younger OIF/OEF veterans.

Project Objectives: The goal of this proposal is to examine the efficacy of an evidence-based gender-specific model of treatment for women veterans with SUD in comparison to a control condition that is not gender-specific (12-Step Facilitation). The long-term objective is to improve treatment outcomes for women veterans with SUD through use of a gender-specific model that is designed to be sensitive to women's unique needs.

Project Methods: We plan to conduct a randomized clinical trial in which women veterans with SUD are assigned to either a gender-specific model of treatment (A Woman's Path to Recovery; WPR), or to a control condition (12-Step Facilitation; 12SF); the latter does not include gender-specific treatment. We will recruit 102 women veterans, ages 18-65, who are diagnosed with SUD and in 11/2012 the protocol was amended to have used substances in the last 90 days. In 9/2011, the protocol was amended to include patients in residential care. Their substance use 90-days prior to residential treatment will be measured for baseline data. Our target is 66 randomized patients. The treatment phase will consist of 12 weeks of weekly therapy; all participants will receive treatment-as-usual (any other treatments they choose to attend). Assessments will be conducted at baseline, Months 1 and 2, end of treatment and 3 month follow up. The study is powered to detect an effect of .80 at a .05 level of significance with this sample size. Cross-sectional, repeated measures and longitudinal analyses are proposed. The primary outcome variable is substance use, with a variety of secondary outcomes (e.g., psychosocial functioning, psychiatric symptoms, coping skills, 12-step attendance) also being explored. We will evaluate potential mechanisms of action of WPR as a secondary question of interest. Biological measures are included to validate substance use self-report of participants. We hypothesize that participants in the experimental condition (WPR) will have more positive outcomes on both primary and secondary variables, and a higher level of treatment satisfaction compared to those in the control condition (12SF) and that mediators/moderators of outcomes (i.e., mechanisms of action) will be knowledge of gender-specific substance abuse recovery concepts and use of coping skills.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Female veteran

18-65 years of age

Meet DSM-IV criteria for current SUD with "current" defined as meeting SUD criteria per the DSM-IV and having used a substance within the 90 days prior to intake (to be able to accurately evaluate changes in their substance use from baseline)

Plan to stay in the Boston area for the next 6 months

Have a mailing address and live close enough to come to the hospital once weekly for treatment and/or assessment

Able to complete the Statement of Informed Consent

Willing to participate in all assessments and breathalyzer/urine testing

Willing to provide a release of information such that study staff can contact her other providers as needed regarding any concerns during her participation

Able to obtain medical clearance

Willing to allow us to contact family and/or friends if participant loses contact with us

Literate

Not pregnant or planning to become pregnant

Exclusion Criteria:

Any acute medical condition that would interfere with the participant's ability to participate in treatment, or would be of such severity as to affect the individual's psychological functioning (e.g., cancer)

Current bipolar I disorder, schizophrenia or other psychotic disorders or mental retardation or organic mental disorder (determined by screening interview)

Any clinical sign that the client is not sufficiently stable to participate in the treatment, such as client's treatment provider indicating that participation in the treatment would be contraindicated

Dangerousness that would present a threat to other staff or other clients (e.g., history of recent assault)

Client is mandated to treatment

Psychopharmacologic treatment that is planned to change or likely to change substantively over the 3-month active treatment phase (with "substantive" defined as any addition of a new medication or major shift in dosage)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734903